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药物片剂或胶囊剂的临床应用,常常因非同一厂家生产,剂型虽同,而疗效不一。其主要原因与药物的生物利用度不同有关。生物利用度狭义的含意是指药物被吸收进入全身血液循环的程度,代表药物在多大程度上被机体所利用;广义上亦包括药物的吸收率。生物利用度在人和动物服药后,通过血、尿或唾液中的浓度来测定,该实验工作量极大,过程复杂,代价较高,且很多客观检查方法不灵敏或根本没有,实际工作是有困难的。由于药物在体内的吸收和生物利用度与药物溶解状态有极大关系,因此,制定体外溶出试验用以反映体内可能吸收的情况是必要的。溶出度合格与否,是临床用药疗效一致安全合理的关键。
The clinical application of the drug tablets or capsules, often due to the same manufacturer, although the same dosage form, and the effect is different. The main reason is related to the different bioavailability of drugs. The narrow meaning of bioavailability refers to the degree to which the drug is absorbed into the systemic blood circulation and represents to what extent the drug is utilized by the body; in a broad sense, the absorption rate of the drug is also included. Bioavailability is determined by the concentration in blood, urine or saliva after taking medicine in humans and animals. This experiment is extremely laborious, complicated and costly, and many of the objective tests are insensitive or nonexistent Difficulties. Because drug absorption and bioavailability in the body are strongly related to the state of drug dissolution, it is necessary to develop an in vitro dissolution test to reflect the potential absorption in the body. Dissolution qualified or not, is the same efficacy of clinical medication safety and reasonable key.